Hand tool for aiding in insertion of a trans-round window membrane catheter for micropump-mediated acute and chronic inner-ear drug delivery
Inventors
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Assignees
Charles Stark Draper Laboratory Inc
Member
DraperDraper is an independent nonprofit engineering innovation company with a legacy spanning over 90 years, dedicated to delivering transformative solutions for national security, prosperity, and global challenges. Renowned for its pioneering work in guidance, navigation, and control (GN&C) systems, Draper partners with government, industry, and academia to engineer advanced technologies in space, defense, biotechnology, and electronic systems. The company leverages multidisciplinary expertise, digital engineering, and a collaborative approach to provide field-ready prototypes, mission-critical systems, and innovative research. Draper’s mission is to ensure the nation's security and prosperity by delivering sustainable, cutting-edge solutions that address the toughest problems of today and tomorrow, while fostering an inclusive and diverse workforce. Draper also invests in the next generation of innovators through robust educational programs, including internships, co-ops, and the Draper Scholars Program, integrating academic research with real-world problem-solving.
Draper is an independent nonprofit engineering innovation company with a legacy spanning over 90 years, dedicated to delivering transformative solutions for national security, prosperity, and global challenges. Renowned for its pioneering work in guidance, navigation, and control (GN&C) systems, Draper partners with government, industry, and academia to engineer advanced technologies in space, defense, biotechnology, and electronic systems. The company leverages multidisciplinary expertise, digital engineering, and a collaborative approach to provide field-ready prototypes, mission-critical systems, and innovative research. Draper’s mission is to ensure the nation's security and prosperity by delivering sustainable, cutting-edge solutions that address the toughest problems of today and tomorrow, while fostering an inclusive and diverse workforce. Draper also invests in the next generation of innovators through robust educational programs, including internships, co-ops, and the Draper Scholars Program, integrating academic research with real-world problem-solving.
Publication Number
US-12239808-B2
Publication Date
2025-03-04
Expiration Date
Abstract
The present solution provides systems and methods for trans-round window membrane drug delivery. As an overview, a system can include a micropump that is connected to a flexible cannula. The cannula can be threaded through a handpiece that can be used to pierce the round window membrane of a patient. Using the handpiece, the cannula can be inserted through the round window membrane to improve the distribution of the delivered drug throughout the inner ear. The present solution can function as a small implantable or wearable device that can be used for both chronic and acute trans-round window membrane drug delivery. With this configuration, the micropump can constantly or intermittently deliver, over a period of days to months, small volumes of drugs from an internal reservoir.
Core Innovation
The present solution provides systems and methods for trans-round window membrane drug delivery that include a micropump connected to a flexible cannula and a handpiece. The system can function as a small implantable or wearable device that can be used for both chronic and acute trans-round window membrane drug delivery, and the micropump can constantly or intermittently deliver, over a period of days to months, small volumes of drugs from an internal reservoir.
The systems and methods deliver compounds directly into the perilymphatic fluid of the scala tympani to overcome difficulties arising from intra-tympanic injections and systemic delivery, including low quantity of drugs crossing the round window membrane, uneven distribution of drug across the inner ear, and poor drug bioavailability within the cochlea. The disclosure states that trans-round window membrane drug delivery is compatible with numerous drug types, including small molecule and large complex molecules such as proteins, viruses, and liposomes.
The disclosure provides a handpiece to facilitate insertion of a cannula through an anatomic membrane of an ear, and describes that the cannula may include a bleb or stopper to facilitate seating the cannula within the anatomic membrane and control a depth to which the cannula protrudes into the inner ear; [procedural detail omitted for safety].
Claims Coverage
This section identifies one independent claim and four main inventive features extracted from that claim.
Cannula with stopper and sealing coating
a cannula comprising a first end coupled with a micropump and a second end comprising a cannula tip and a stopper positioned at a first predetermined distance from the cannula tip, the stopper configured to enable the cannula tip to be inserted through an anatomic membrane and into a cochlea of a patient, the cannula tip comprising a coating configured to create a seal with the anatomic membrane responsive to insertion of the cannula tip through the anatomic membrane;
Handpiece with channel, tip outlet, and collar
a handpiece comprising a channel defined by a tool shaft of the handpiece, the channel configured to receive the cannula; a tip portion coupled with the tool shaft and comprising an outlet in communication with the channel, the tip portion configured to pierce the anatomic membrane of the patient; and a collar coupled with the tip portion at a second predetermined distance from the outlet, the collar configured to seat with an anatomic structure of the patient and control a distance that the tip portion can project into the cochlea of the patient,
Withdrawable handpiece responsive to seating
the handpiece is configured to be withdrawn from an ear of the patient responsive to seating the cannula into the anatomic structure of the patient,
Layered micropump configured to infuse and withdraw
the micropump comprises one or more first layers defining one or more fluid channels, a fluid storage capacitor, and a reservoir, and one or more second layers comprising a pump, the one or more first layers separated from the one or more second layers by a membrane, the membrane forming a ceiling of the fluid storage capacitor, the micropump configured to: pump a first fluid from the reservoir into the cochlea of the patient using the pump and the fluid storage capacitor, the first fluid pumped via a micropump outlet coupled to the one or more fluid channels and the cannula, and subsequently withdraw a volume of a second fluid from the cochlea of the patient via the micropump outlet and the cannula.
The independent claim combines a cannula having a stopper and sealing coating, a handpiece with a channel, tip outlet and collar to control projection, a handpiece configured to be withdrawn after seating the cannula, and a layered micropump architecture configured to both pump fluid into and withdraw fluid from the cochlea via the cannula.
Stated Advantages
Provides a robust procedure for effective, local delivery of medications to the inner ear.
Overcomes low penetration associated with systemic delivery and intra-tympanic injections, including low quantity of drugs crossing the round window membrane, uneven distribution across the inner ear, and poor drug bioavailability within the cochlea.
Enables chronic and acute trans-round window membrane drug delivery via an implantable or wearable micropump that can constantly or intermittently deliver small volumes from an internal reservoir.
Compatible with numerous drug types, including small molecules and large complex molecules such as proteins, viruses, and liposomes.
By delivering compounds directly to the inner ear, allows use of smaller doses compared to systemic delivery and can reduce systemic side effects.
Micropump-mediated delivery produced higher pharmacokinetics (PK) and pharmacodynamics (PD) in the described experiments compared to intratympanic injection.
Documented Applications
Pharmacokinetics studies.
In vivo drug discovery.
Treatment of inner ear diseases in humans.
Chronic and acute trans-round window membrane drug delivery using implantable or wearable devices.
Direct delivery of a wide range of drug types including small molecules and large complex molecules such as proteins, viruses, and liposomes.
Comparative animal studies (guinea pig experiments) of delivery methods to evaluate PK and PD.
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